DEVICE: System One Heated Humidifier (00606959006614)

Device Identifier (DI) Information

System One Heated Humidifier
00
In Commercial Distribution
DS6T
Respironics, Inc.
00606959006614
GS1
December 31, 9999
1
080728314 *Terms of Use
System One Heated Humidifier, Domestic
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Heated respiratory humidifier A mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
BZD VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K113068 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

c3001ecd-f36f-49b7-92d1-0ceed794db35
July 06, 2018
3
August 20, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(724)744-2500
respironics.service@philips.com
CLOSE